title: A combined community- and facility-based approach to improve pregnancy outcomes in low-resource settings: a Global Network cluster randomized trial.
abstract: BACKGROUND
  Fetal and neonatal mortality rates in low-income countries are at least 10-fold greater than in high-income countries. These differences have been related to poor access to and poor quality of obstetric and neonatal care.
  
  
  METHODS
  This trial tested the hypothesis that teams of health care providers, administrators and local residents can address the problem of limited access to quality obstetric and neonatal care and lead to a reduction in perinatal mortality in intervention compared to control locations. In seven geographic areas in five low-income and one middle-income country, most with high perinatal mortality rates and substantial numbers of home deliveries, we performed a cluster randomized non-masked trial of a package of interventions that included community mobilization focusing on birth planning and hospital transport, community birth attendant training in problem recognition, and facility staff training in the management of obstetric and neonatal emergencies. The primary outcome was perinatal mortality at ≥28 weeks gestation or birth weight ≥1000 g.
  
  
  RESULTS
  Despite extensive effort in all sites in each of the three intervention areas, no differences emerged in the primary or any secondary outcome between the intervention and control clusters. In both groups, the mean perinatal mortality was 40.1/1,000 births (P = 0.9996). Neither were there differences between the two groups in outcomes in the last six months of the project, in the year following intervention cessation, nor in the clusters that best implemented the intervention.
  
  
  CONCLUSIONS
  This cluster randomized comprehensive, large-scale, multi-sector intervention did not result in detectable impact on the proposed outcomes. While this does not negate the importance of these interventions, we expect that achieving improvement in pregnancy outcomes in these settings will require substantially more obstetric and neonatal care infrastructure than was available at the sites during this trial, and without them provider training and community mobilization will not be sufficient. Our results highlight the critical importance of evaluating outcomes in randomized trials, as interventions that should be effective may not be.
  
  
  BACKGROUND
  ClinicalTrials.gov NCT01073488.
authors.affiliation: Department of Community Health Sciences, Aga Khan University, Karachi, Pakistan. omrana.pasha@aku.edu.
authors.forename: Omrana
authors.initials: O
authors.lastname: Pasha
authors.forename: Elizabeth M
authors.initials: EM
authors.lastname: McClure
authors.forename: Linda L
authors.initials: LL
authors.lastname: Wright
authors.forename: Sarah
authors.initials: S
authors.lastname: Saleem
authors.forename: Shivaprasad S
authors.initials: SS
authors.lastname: Goudar
authors.forename: Elwyn
authors.initials: E
authors.lastname: Chomba
authors.forename: Archana
authors.initials: A
authors.lastname: Patel
authors.forename: Fabian
authors.initials: F
authors.lastname: Esamai
authors.forename: Ana
authors.initials: A
authors.lastname: Garces
authors.forename: Fernando
authors.initials: F
authors.lastname: Althabe
authors.forename: Bhala
authors.initials: B
authors.lastname: Kodkany
authors.forename: Hillary
authors.initials: H
authors.lastname: Mabeya
authors.forename: Albert
authors.initials: A
authors.lastname: Manasyan
authors.forename: Waldemar A
authors.initials: WA
authors.lastname: Carlo
authors.forename: Richard J
authors.initials: RJ
authors.lastname: Derman
authors.forename: Patricia L
authors.initials: PL
authors.lastname: Hibberd
authors.forename: Edward K
authors.initials: EK
authors.lastname: Liechty
authors.forename: Nancy
authors.initials: N
authors.lastname: Krebs
authors.forename: K Michael
authors.initials: KM
authors.lastname: Hambidge
authors.forename: Pierre
authors.initials: P
authors.lastname: Buekens
authors.forename: Janet
authors.initials: J
authors.lastname: Moore
authors.forename: Alan H
authors.initials: AH
authors.lastname: Jobe
authors.forename: Marion
authors.initials: M
authors.lastname: Koso-Thomas
authors.forename: Dennis D
authors.initials: DD
authors.lastname: Wallace
authors.forename: Suzanne
authors.initials: S
authors.lastname: Stalls
authors.forename: Robert L
authors.initials: RL
authors.lastname: Goldenberg
mesh_terms: D000328:Adult; D015331:Cohort Studies; D003906:Developing Countries; D005260:Female; D006700:Home Childbirth; D006801:Humans; D008428:Maternal Mortality; D009359:Neonatology / Q000379:methods*; D009774:Obstetrics / Q000379:methods*; D054238:Perinatal Mortality; D011247:Pregnancy; D011256:Pregnancy Outcome; D011295:Prenatal Care / Q000379:methods*; D055815:Young Adult